Adare Pharmaceuticals, Inc.
Form 483 issued February 25, 2025 · Vandalia, Ohio
- Inspection
- Feb 18 – Feb 25, 2025
- Investigator
- Geoffrey K. Kilili
- Observations
- 1
- Pages
- 3
- FEI number
- 1525864
In short: On February 25, 2025, FDA issued a Form 483 with 1 observation to Adare Pharmaceuticals, Inc. in Vandalia, Ohio (FEI 1525864) after an inspection that ran Feb 18 – Feb 25, 2025. The investigator was Geoffrey K. Kilili. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×)
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Geoffrey K. Kilili
7 documents · 2021–2025
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Ohio.
The firmAdare Pharmaceuticals, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Adare Pharmaceuticals, Inc.?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Adare Pharmaceuticals, Inc.?
Geoffrey K. Kilili is named on this Form 483, for the inspection of Feb 18 – Feb 25, 2025. Each investigator has a profile showing what they cite most.
When was Adare Pharmaceuticals, Inc. inspected by FDA?
The inspection ran Feb 18 – Feb 25, 2025, and the Form 483 is dated February 25, 2025.
How do I get the full Form 483 for Adare Pharmaceuticals, Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.